Země: Malta
Jazyk: angličtina
Zdroj: Medicines Authority
LEVOFLOXACIN
Fresenius Kabi Limited
J01MA12
LEVOFLOXACIN
SOLUTION FOR INFUSION
LEVOFLOXACIN 5 mg/ml
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Authorised
2009-10-21
1 PACKAGE LEAFLET: INFORMATION FOR THE USER LEVOFLOXACIN 5MG/ML SOLUTION FOR INFUSION. Levofloxacin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Levofloxacin is and what it is used for 2. Before you are given Levofloxacin 3. How Levofloxacin is given 4. Possible side effects 5. How to store Levofloxacin 6. Further information 1. WHAT LEVOFLOXACIN IS AND WHAT IT IS USED FOR Levofloxacin is an antibiotic of the fluoroquinolone class. Antibiotics medicines work by killing bacteria that cause infections. Levofloxacin is indicated in adults for the treatment of the following infections: - Community-acquired pneumonia. - Complicated (difficult to treat) urinary tract infections including pyelonephritis (infection of the kidney). - Chronic infection of the prostate. - Skin and soft tissue infections. 2. BEFORE YOU ARE GIVEN LEVOFLOXACIN DO NOT USE LEVOFLOXACIN - if you are allergic (hypersensitive) to levofloxacin, to any other quinolone antibiotic or to any of the other ingredients of Levofloxacin - if you suffer from seizure disorders (epilepsy). - if you have ever had tendons problems (e.g. tendinitis) related to treatment with fluoroquinolone antibiotics. This is because there is a risk of get Přečtěte si celý dokument
Page 1 of 19 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Levofloxacin 5mg/ml solution for infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 50 ML FILLED IN 100 ML BOTTLE: Each ml of solution for infusion contains 5 mg levofloxacin (as levofloxacin hemihydrate). 50 ml of solution for infusion contains 250 mg of levofloxacin as active substance. 100 ML FILLED IN 100 ML BOTTLE: Each ml of solution for infusion contains 5 mg levofloxacin (as levofloxacin hemihydrate). 100 ml of solution for infusion contains 500 mg of levofloxacin as active substance. Excipients: The medicinal product contains 3.5 mg of sodium per ml _For a full list of excipients, see section 6.1 _ 3. PHARMACEUTICAL FORM Solution for infusion. Yellow to greenish yellow solution 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In adults for whom intravenous therapy is considered to be appropriate, Levofloxacin Kabi solution for infusion is indicated for the treatment of the following infections when due to levofloxacin-susceptible microorganisms: - Community-acquired pneumonia. - Complicated urinary tract infections including pyelonephritis. - Chronic bacterial prostatitis. - Skin and soft tissue infections. Consideration should be given to national and/or local guidance on the appropriate use of fluoroquinolones. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Levofloxacin Kabi solution for infusion is administered by slow intravenous infusion once or twice daily. The dosage depends on the type and severity of the infection and the sensitivity of the presumed causative pathogen. It is usually possible to switch from initia Přečtěte si celý dokument